FDA Inspection
INI Botanicals IncINI Botanicals Inc – FDA Inspection, Mar 3, 2016
Record Details
This FDA Inspection record concerns INI Botanicals Inc, with an inspection on March 3, 2016, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
- Company
- INI Botanicals Inc
- Inspection Date
- March 3, 2016
- Product Type
- Food/cosmetics
View Company Profile
ID · 202753d3-1504-4760-904d-000c36abad29
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 962352
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
FDA Citations
8- 21 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient
- 21 CFR 111.353Manufacturing operations - written procedures
- 21 CFR 111.70(b)(2)Specifications-component purity, strength, composition
- 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
- 21 CFR 111.65Quality control - quality, dietary supplement
- 21 CFR 111.75(a)(2)(ii)(C)Documentation - qualify supplier
- 21 CFR 111.205(a)Master manufacturing record - unique formulation
- 21 CFR 111.255(b)Batch record - complete
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